CorMedix Inc. has announced that the US Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application for DefenCath, a catheter lock solution that is being developed to reduce catheter-related bloodstream infections in patients with kidney failure who are receiving chronic hemodialysis via a central venous catheter. The FDA considers the resubmission as a complete, Class 2 response with a six-month review and has assigned a Prescription Drug User Fee Act target action date of November 15, 2023. CorMedix is working towards launching DefenCath commercially and expects to provide additional updates over the coming months.
CorMedix is a biopharmaceutical company focused on developing therapeutic products for life-threatening conditions and diseases. Its lead product, DefenCath, has been designated by the FDA as Fast Track and as a Qualified Infectious Disease Product, which provides an additional five years of marketing exclusivity upon approval of the NDA.
Keywords: CorMedix Inc., FDA, New Drug Application, DefenCath, catheter lock solution. Biopharmaceutical company CorMedix Inc. has